Kornimate/medical-research-clean huggingface dataset:
cytomegalovirus (cmv) vaccine in donors and recipients undergoing allogeneic hematopoietic cell transplant (hct)

Conditions: Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Myelodysplastic Syndrome

Summary: the purpose of this trial is to evaluate a cmv vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and cmv-seropositive recipients just before and after transplantation) and cmv-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of cmv infection, disease, and other complications from immunosuppression and/or transplantation. the outcomes for the groups receiving cmv vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. for this trial, donors and recipients must have matched hla genotype (matched at 5/6 or 6/6 hla loci).

this study was run by vical and the record was transferred to astellas on 1/8/2013. trial will enroll up to 240 subjects (160 recipients and 80 donors). qualified donors and/or cmv-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be assigned randomly to receive either a cmv vaccine or a placebo vaccine. donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant. recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the cmv vaccine. the incidence rates of cmv infection, disease, and other complications from immunosuppression and/or transplantation will be studied.

Eligibility criteria:
inclusion criteria: * males and females age 18-65 * 5/6 or 6/6 classic hla allele-matched donor * planned gcsf-mobilized peripheral blood stem cell transplant * cmv-seropositive recipient * planned transplant with minimal or no t-cell depletion * acute lymphoblastic leukemia (all) in first or second remission; acute myeloid leukemia (aml) in first or second remission; chronic myelogenous leukemia (cml) in first chronic or accelerated phase, or in second chronic phase; hodgkin's and non-hodgkin's lymphoma; myelodysplastic syndrome exclusion criteria: * planned prophylactic cytomegalovirus antiviral therapy * planned immunosuppression with alemtuzumab (campath-ih) * planned prophylactic therapy with cmv immunoglobulin * autoimmune disease

Keywords: cytomegalovirus infection infectious disease viremia cytomegalovirus disease stem cell transplant allogeneic bone marrow transplant hematopoietic cell transplant acute lymphoblastic leukemia chronic myelogenous leukemia acute myelogenous leukemia hodgkin's lymphoma non-hodgkin's lymphoma myelodysplastic syndrome
ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin qd in subjects with genotype 1a chronic hepatitis c virus infection

Conditions: Hepatitis C Virus (HCV)

Summary: this study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (gt1a) hepatitis c virus infected participants who are treatment-naïve or treatment-experienced with interferon (ifn) or pegylated interferon (pegifn) with or without ribavirin (rbv).


Eligibility criteria:
inclusion criteria: * chronic hepatitis c virus (hcv) infection * non-cirrhotic subjects * screening laboratory results showing hcv genotype 1a (hcv gt1a) infection * hcv treatment-naïve or if treated previously, only with interferon (ifn) or pegylated interferon (peginf) with or without ribavirin (rbv) exclusion criteria: * pregnant or breastfeeding women * positive for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) * hcv genotype of any subtype other than gt1a or unable to subtype * prior or current use of any investigational or commercially available anti-hcv agents other than ifn, pegifn or rbv. subjects with previous participation in trials of investigational direct-acting antiviral agents (daas) may be enrolled if they can produce documentation that they received only placebo. * current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

Keywords: chronic hepatitis c infection
non-interventional study (nis) collecting experiences for ipf in taiwan

Conditions: Pulmonary Fibrosis

Summary: this is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (ipf) in clinical practice in taiwan. the study will be carried out at 10 medical centers, the expert centers where ipf patients are mainly managed in taiwan.


Eligibility criteria:
inclusion criteria: * patients can be included if all the following criteria are met: 1.newly diagnosed with ipf within 6 months based upon recent ats/ers/jrs/alat ipf guideline (ref 1, raghu g, et al. 2011). * exclusion of other known causes of ild (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity). * assessment of ipf based on hrct or hrct and surgical lung biopsy, if available. 2.patient ≥ 20 years of age 3.written informed consent prior to participation 4.patients with further follow-up possible with participating physician during planned study period 5.ability to read and write in the local language exclusion criteria: * patients should not be included if any of the following criteria is met: 1. lung transplantation expected within next 6 months. 2. inclusion in ongoing clinical trials.
usefulness of cardiovascular disease (cvd) management solution

Conditions: Cardiovascular Diseases

Summary: we previously developed the smartphone app (heart4u) which is coupled with electronic medical record system in seoul national university bundang hospital. in this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.


Eligibility criteria:
inclusion criteria: * patients with atherosclerotic cardiovascular diseae 1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina) 2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery 3. history of stroke 4. history of peripheral arterial disease presumed to be of atherosclerotic origin * patients who have smartphone and can use app by themselves * patients who can speak and read korean language exclusion criteria: * patients with evidences of delirium, confusion or impaired consciousness * patients who are not familiar to smartphone or app * patients who are not supposed to follow the study protocol adequately.
tnf-alpha inhibition for treatment of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: it is widely believed that inflammation contributes to the pathogenesis of ad. tnf has been implicated in both ad and neurological inflammation. anti-tnf therapy is therefore surmised to be of potential benefit for treating ad.

etanercept, a biologic anti-tnf fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.

Eligibility criteria:
inclusion criteria: * nincds-adrda criteria for alzheimer's disease * ct or mri consistent with ad exclusion criteria: * active infection * chf * demyelinating disease * uncontrolled diabetes mellitus * vascular dementia * clinically significant neurologic disease other than ad * hachinski \>4 * history of lymphoma * tbc * wbc\<2500 * platelets\<100,000 * hct\<30 * pregnancy * premenopausal, fertile not on acceptable birth control * change in neuroactive medication within 4 weeks of study initiation
cbct for parents of children with autism

Conditions: Stress

Summary: the purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol.

a pilot-test, eight week, cognitive based compassion training (cbct) program for caregivers of children with developmental delays that is comprised of eight two-hour weekly long sessions with a certified instructor followed by a twenty minute long meditation session. sessions will focus on developing attention and stability of mind through focused attention training; cultivating insight into the nature of mental experience; cultivating self-compassion; developing equanimity; developing appreciation and gratitude; developing affection and empathy; realizing aspirational compassion; and realizing active compassion.

Eligibility criteria:
inclusion criteria: * caregiver of child(ren) with developmental delay (including parents, grandparents, other extended family, family friends, and providers) * spend significant amount of time (more than 10 hours/week) with children with special needs. exclusion criteria: * started to use any psychotropic medication within one year. * had any changes in any psychotropic medication doses taken within one year.

Keywords: caregiver stress depression autism spectrum disorder compassion meditation
telehealth monitoring in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the the aim of this study is to determine the benefits of telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.

chronic obstructive pulmonary disease (copd) is a major burden on healthcare systems worldwide. the current management of patients with copd includes well established interventions such as pulmonary rehabilitation and inhaled therapies which have demonstrated variable impact on reducing rates of exacerbation and improving health related quality of life. telehealth is a home monitoring system used to record clinical observations and carry out question and answer sessions. it has been proposed that telehealth medicine may offer an alternative strategy to the overall management of these patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (copd) * a minimum of two: emergency department admissions; hospital admissions or emergency gp contacts in the 12 months previous to the study exclusion criteria: * any respiratory disorder other than copd * patients cognitively unable to learn the process of monitoring

Keywords: copd telehealth health related quality of life
characterization of the analgesic effect of cbd in healthy, normal volunteers

Conditions: Pain

Summary: the purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (cbd), a chemical constituent found in cannabis that does not have intoxicating effects. the analgesic effects of cbd will be assessed using the cold-pressor test (cpt), a laboratory model of pain which has predictive validity for the clinical use of analgesics.

this within-subject, double-blind, placebo-controlled study will assess the analgesic and subjective effects of a range of cbd doses (0, 200, 400, or 800 mg, po). volunteers will participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the analgesic effects of cbd will be assessed using the cold-pressor test (cpt), a laboratory model of pain which has predictive validity for the clinical use of analgesics. the order of cbd dose will be randomized across participants. secondary measures will include subjective and physiologic effects of cbd.

Eligibility criteria:
inclusion criteria: * able to perform study procedures * women practicing an effective form of birth control exclusion criteria: * female subjects who are currently pregnant or breastfeeding. * current illicit drug use * presence of significant medical illness * history of heart disease * request for drug treatment * current parole or probation * recent history of significant violent behavior * major psychiatric disorder * current use of any prescription or over-the-counter medication * current pain * clinically significant raynaud's syndrome
study to assess the cosmetic changes in the facial skin after use of a topical retinoid product in participants with moderate to severe photodamage

Conditions: Skin Care

Summary: this study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.


Eligibility criteria:
inclusion criteria: * participants with fitzpatrick skin type i-iv * presence of moderate to severe facial photodamage * participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study * willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit * willingness to not use any other products, including self-tanners on their facial skin during the study * willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 am to 2 pm. participants are asked to wear protective clothing prior to and during exposure. exclusion criteria: * individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study * individuals who are nursing, pregnant, or planning to become pregnant during the study * individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, active hepatitis, immune deficiency, or autoimmune * individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.) * individuals who require electrolysis, waxing, or use depilatories on the face during the study * chemical peel or microdermabrasion within 4 weeks of study start * retin-a®, retin-a micro®, renova®, avita®,tazorac®, avage® or differin® or other similar prescription drugs within 3 months of study start * cosmetic injections (filler and/or toxins, i.e. juvederm, radiesse, botox, etc.), non-ablative laser or fractional laser resurfacing * accutane® or other oral retinoid, ablative procedures (i.e. laser, chemical, cosmetic surgeries) within 12 months of study start * participants who have planned surgeries or procedures.
estimated echocardiographic pulmonary capillary wedge pressure in heart failure

Conditions: Heart Failure

Summary: the aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (pcwp), determined by doppler echocardiography and tissue doppler imaging in patients suffering from compensated heart failure.

the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.

Eligibility criteria:
inclusion criteria: * compensated hf patients exclusion criteria: * decompensated hf patients

Keywords: sodium ,diuretics, pcwp
clinical evaluation of two daily disposable silicone hydrogel contact lenses

Conditions: Myopia

Summary: the purpose of this study was to compare the subjective performance of dailies total1® daily disposable contact lenses to that of 1-day acuvue® trueye® daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * sign written informed consent document and hipaa form. * be current weekly/monthly replacement contact lens wearer. * be willing to not sleep in contact lenses during the study period. * require vision correction in both eyes, with a contact lens prescription in protocol-specified power range. * have best corrected visual acuity of at least 20/25 in each eye. * be willing to wear study lenses for at least 8 hours/day and at least 5 days/week. * use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses. * other protocol-specified inclusion criteria may apply. exclusion criteria: * be a neophyte or current wearer of daily disposable lenses. * require monovision correction or use multifocal contact lenses. * have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study. * have a history of ocular surgery/trauma within the last 6 months. * use topical ocular or systemic antibiotics within 7 days of enrollment. * use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study. * have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment. * use re-wetting drops once or more per day. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses myopia
fluorescence, light-microscopy, ultrasound integrated / intraoperative diagnosis to maximise resection

Conditions: Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma

Summary: the present study aims to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of high grade gliomas (hggs)

extent of resection represents the cornerstone of surgery in terms of improving the prognosis of the patient with high grade gliomas, but total removal of neoplastic tissue is prevented by the amount of infiltration that is undetectable either by traditional preoperative mri techniques or by the naked eye during surgery. several techniques are currently used to define margins in the surgical setting, but the literature available on them to date is mostly focused on the assessment of postoperative gtr (gross total resection), which tends to underestimate neoplastic tissue infiltration. the evaluation of the efficacy of these techniques in detecting tumour infiltration by comparing them with the histopathology response on intraoperative biopsies taken after the debulking phase of the neoplasm could overcome this sensitivity limitation. the study therefore intends to develop an algorithm that allows to discern between tumour infiltration and healthy parenchyma by means of different margin-assessment techniques in order to maximise the extent of resection in patients with hggs.

Eligibility criteria:
inclusion criteria: patients with radiological, clinical and anamnestic picture compatible with a new diagnosis of glioblastoma for whom there is an indication for cytoreductive surgery at the fondazione i.r.c.c.s. istituto neurologico carlo besta. exclusion criteria: * patients aged less than 18 years at the time of radiological diagnosis * patients who have received radiation therapy in the same area as the neoplasm of interest * patients contraindicated to 5-ala administration * patients whose neoplasm is in close proximity to functionally eloquent areas (primary motor, broca's, wernicke's areas) * patients who have not given their consent to take part in the research
genetic markers of circulating tumor dna for monitoring breast cancer patients in costa rica

Conditions: Metastatic Breast Cancer; Mutation, Point

Summary: the use of circulating tumor dna (ctdna) as a noninvasive test for breast cancer monitoring throughout the course of the disease

the concentrations of the cell free dna (cfdna) and somatic mutations in circulating tumor dna (ctdna) in serial samples correlate with the number of days of the progression-free period and with the overall survival.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer before the start of chemotherapeutic treatment exclusion criteria: * patients with incomplete clinical records
carbonic anhydrase ix enzyme in triple negative breast carcinoma

Conditions: Triple Negative Breast Cancer; Carbonic Anhydrase IX

Summary: triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and her2/neu receptors. carbonic anhydrase ix (ca ix) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. this study aimed to investigate ca ix expression in tnbc and its relationship with treatment effect.

tru-cut biopsy materials, sent to our hospital pathology laboratory between august 2018 and may 2023, will be examined. invasive carcinoma cases will be evaluated according to estrogen, progesterone, and her 2 receptor levels. triple-negative tumor cases were isolated and those cases who underwent breast resection in our hospital after receiving neoadjuvant chemotherapy (adriamycin, cyclophosphamide, and then paclitaxel for 4 cycles) were included in the study.

Eligibility criteria:
inclusion criteria: * older than 18 years * triple-negative mastectomy cases * patients whose data can be available * patients who were operated in our hospital exclusion criteria: * younger than 18 years * not triple negative mastectomy cases * patients with missing data * patients who were operated in another hospital

Keywords: triple negative breast carcinoma carbonic anhydrase ix treatment effect ki67 proliferation index
phase ii randomized study of stereotactic radiosurgery plus fractionated whole-brain radiotherapy vs fractionated whole-brain radiotherapy alone for multiple primary or metastatic brain tumors

Conditions: Brain Neoplasms

Summary: objectives: i. evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function. ii. examine survival, clinical outcome, and local tumor imaging response in these patients.

protocol outline: this is a randomized study. tumor size and number are confirmed prior to randomization. patients are stratified by participating institution. patients are randomly assigned to 1 of 2 treatment groups. one group is treated with fractionated whole-brain irradiation using megavoltage equipment. the second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. either treatment may be administered first; the second treatment begins within 1 month of the first. concurrent anticonvulsants and steroids are allowed. patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Eligibility criteria:
* multiple newly diagnosed brain tumors * histologic confirmation of carcinoma at primary or metastatic site * tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm * no more than 4 tumors on magnetic resonance imaging * systemic disease controlled * neurologic function preserved * radiographic staging within 2 months of randomization required * performance status: karnofsky 70%-100%

Keywords: adult brain tumor brain tumor childhood brain tumor genetic condition nervous tissue tumors oncologic disorders rare disease